In addition to its antiviral developments, Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP)is also progressing with its New dr-ug Application (NDA) for TNX-102 SL (conditionally accepted trade name Tonmya™) for the treatment of fibromyalgia (FM). Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) plans to submit the NDA in the second half of 2024, following productive meetings with the FDA. On June 20, 2024, Tonix received formal minutes from a pre-NDA Type B Chemistry, Manufacturing, and Controls (CMC) meeting, indicating alignment with the FDA on key topics such as proposed dr-ug substance and dr-ug product commercial specifications, shelf life assignment, manufacturing, and commercial dr-ug packaging. On July 8, 2024, Tonix received formal minutes from a pre-NDA meeting regarding the proposed data package. The company and the FDA agreed that the proposed data package is sufficient to support NDA submission. Recently, Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced key findings from the initial phase of a market opportunity analysis conducted by EVERSANA. The analysis revealed a high level of interest in Tonmya among physicians treating fibromyalgia patients, many of whom expressed dissatisfaction with currently FDA-approved therapies. Key findings include a significant amount of off-label prescribing, with opioids and gabapentin being commonly used, and a high rate of failure with first-line therapy. Approximately 50% of U.S. fibromyalgia patients are on Medicare. Starting in 2025, Medicare Part D will cap annual out-of-pocket costs at $2,000 and offer enrollees the option to pay these costs in capped monthly installments, which could provide Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) with considerable pricing power for Tonmya. David Bautz, Ph.D., analyst at Zacks, now has an $8.00 target on Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), suggesting a potential upside of 1,200% from Wednesday's (7/24/2024) open of $0.6001.
7 Reasons why Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) needs to be at the top of your watchlist. - Strategic Partnership with DoD: Tonix Pharmaceuticals has secured a five-year collaboration with the U.S. Department of Defense, bringing up to $34M in funding to develop broad-spectrum antiviral agents.
- Cutting-Edge Antiviral Research: The company's innovative approach focuses on fortifying the immune system to combat a wide range of viral threats, addressing the growing concerns of biological warfare and synthetic biology.
- Government Sponsorship: Backed by the DTRA's Chemical and Biological Technologies Department, Tonix's research is part of a significant $1.9B budget for fiscal 2024, emphasizing the importance of advanced antiviral solutions.
- Development of TNX-4200: Tonix's focus on the oral CD45 antagonist TNX-4200 aims to provide broad-spectrum efficacy against various viral pathogens, moving beyond the traditional "one bug, one dr-ug" model.
- Growing Market Demand: With the broader antiviral market projected to reach $74.75B by 2028, Tonix's innovative solutions are well-aligned with the increasing global demand for effective antiviral treatments.
- Tonmya™ NDA Progress: In addition to its antiviral initiatives, Tonix is making strides in the treatment of fibromyalgia with the NDA filing for TNX-102 SL (Tonmya™) on track for the second half of 2024, supported by positive feedback from the FDA.
- Analyst Target: Analyst David Bautz, Ph.D., from Zacks, has set an $8.00 target for Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), suggesting a potential upside of 1,200% from the current trading price of $.6001 (as of 7/24/2024).
With a strategic partnership with the U.S. Department of Defense, securing up to $34M in funding, Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is positioned for groundbreaking advancements in broad-spectrum antiviral agents. Their cutting-edge research focuses on fortifying the immune system to combat a wide range of viral threats, addressing critical concerns about biological warfare and synthetic biology. Supported by the DTRA's significant budget, Tonix's innovative solutions are aligned with the increasing global demand for effective antiviral treatments. Tonix's development of TNX-4200, an oral CD45 antagonist, promises broad-spectrum efficacy against various viral pathogens. Their state-of-the-art research facilities in Maryland further bolster their capabilities in vaccine and antiviral dr-ug development. Additionally, Tonix is making significant progress with their Tonmya™ NDA for the treatment of fibromyalgia, set for submission in the second half of 2024. Analyst David Bautz, Ph.D., from Zacks, has set an ambitious $8.00 target for Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), indicating a potential upside of 1,200% from the current trading price. With such promising developments and strong backing, now is the perfect time to start your research on Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP). Don't miss out on this one.
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